DETAILED ACTION
Election/Restrictions
Applicant’s election of Group I, claims 1-8, and selected species in the reply filed on March 5, 2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant has elected sequons NFT, YANET and FHNAT in claim 2. In the election of species requirement, Applicant was to elect a corresponding sequence from claims 3-5 and 8, commensurate in scope with the elected sequons. Applicant elected SEQ ID NO: 67 from claims 3-5 and 8, however, SEQ ID NO: 67 comprises four sequon sequences: NAT, NFT, YANET and FHNAT. Therefore, in addition to the elected sequons NFT, YANET and FHNAT in claim 3, the sequon NAT is rejoined since it is present in elected sequence SEQ ID NO: 67.
Specification
The disclosure is objected to because of the following informalities:
The amino acid sequences “YANET” and “FHNAT”, and any other amino acid sequence that is four amino acids or longer must be identified with a sequence identifier according to WIPO Standard ST.26. Appropriate correction is required.
Claims Summary
Claim 1 is directed to a polypeptide comprising SEQ ID NO: 80 (elected species), substituted with one or more sequons, wherein the N-terminal residue (which is M) may be present or absent. The sequons are: NAT, NFT, YANET, and FHNAT (claim 2, elected species). A sequon is a sequence of consecutive amino acids that can serve as the attachment site to a polysaccharide (see paragraph [0050] of the published application US 2024/0042018). SEQ ID NO: 80 is 150-aa and represents I53-50A. The polypeptide comprises SEQ ID NO: 67 (elected species) (claims 3-5), reproduced below:
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SEQ ID NO: 67 is 200-aa, and comprises four sequon sequences: NAT, NFT, YANET and FHNAT (claim 3). Each sequon may independently be substituted with any other sequon (claim 3). SEQ ID NO: 67 optionally has an N-terminal signal peptide (X1), and optionally has a purification tag at the C-terminus (X2) (claim 3).
Also claimed is a fusion protein comprising a polypeptide comprising SEQ ID NO: 80 (elected species), substituted with one or more sequons, wherein the N-terminal residue may be present or absent, and a functional domain linked to the polypeptide, either directly or via an optional amino acid linker (claim 6). The functional domain comprises a bacterial antigen, a viral antigen, a fungal antigen, or a cancer antigen (claim 7). The polypeptide comprises SEQ ID NO: 67 (claim 8).
Claim Objections
Claims 1-8 are objected to because of the following informalities:
Claim 1 needs a period at the end of the sentence.
In claim 6, part (a), there should be a space between “claim” and “1”.
Claim 2 recites “YANET” and “FHNAT”, both of which require sequence identifiers according to WIPO Standard ST.26.
In claims 4, 5 and 8, “selection” should be “selected”.
Claim 7 depends from claim 8. A dependent claim must refer to a preceding claim. See MPEP § 608.01(n).
Claim 3 is included in this objection because it depends from claim 1, which is itself objected to. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 6 and 8 are directed to fusion protein embodiments wherein the protein comprises a functional domain. The metes and bounds of a “functional domain” are not set forth in the specification with a definition. The specification has examples of functional domains (see paragraph [0070] of the published application US 2024/0042018) but nothing definitive. The structure of a domain is not provided, nor is the function that renders the domain functional.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to a large genus of polypeptides comprising SEQ ID NO: 80 (I53-50a, which is a nanoparticle scaffold sequence) that has one or more sequon substitutions anywhere along the polypeptide. The claims also encompass a large genus of sequons, sequons being a sequence of consecutive amino acids that can serve as the attachment site to a polysaccharide (see paragraph [0050] of the published application US 2024/0042018). Thus there is no particular structure for the sequon, except in the case of claim 2 where the sequons are defined. While no explicit function is assigned to the polypeptides, SEQ ID NO: 80 is a nanoparticle scaffold sequence, thus the polypeptides have the capability of forming a nanoparticle scaffold sequence.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In this case, Applicant has provided a structure in the form of a base sequence for the scaffold protein, SEQ ID NO: 80, wherein any number of sequons of no particular sequence (except for claim 2) are substituted for any number of residues of SEQ ID NO: 80, anywhere along the 150 amino acids of SEQ ID NO: 80. There is no identification of any particular portion of SEQ ID NO: 80 that must be conserved. As mentioned above, while no explicit function is assigned to the polypeptides in the claims, SEQ ID NO: 80 is a nanoparticle scaffold sequence, thus the polypeptides have the capability of forming a nanoparticle scaffold sequence. The species that Applicant has identified for I53-050A having anywhere between 1 and 4-8 sequons, substituted at the locations shown in SEQ ID NO: 26-48 (1 sequon), SEQ ID NO: 61-77 (between 4-8 sequons), with sequons that have the N_S/T motif, are not representative of the genus encompassed by the claims (i.e., any number of sequons, any sequon, anywhere along the polypeptide). There is no structure-function nexus for the large number of polypeptides having the function of a scaffolding protein. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived.
Amendment of the claims to recite the particular sequons (as in claim 2), the quantity and location of the sequons (as in SEQ ID NO: 67) would overcome this rejection.
Conclusion
No claim is allowed.
SEQ ID NO: 67 is free of the prior art of record.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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